Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Providence Medical Technology, Inc.
ClinicalTrials.gov Identifier:
NCT01616719
First received: June 7, 2012
Last updated: January 13, 2013
Last verified: January 2013
  Purpose

DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for Cervical Degenerative Disc Disease. This study is being conducted to determine the effectiveness of the graft, and to find out whether or not it provides better results or faster healing than traditional ways of performing surgery for Cervical Degenerative Disc Disease.


Condition Intervention
Cervical Spondylosis
Cervical Radiculopathy
Cervical Degenerative Disc Disease
Device: DTRAX Graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease

Further study details as provided by Providence Medical Technology, Inc.:

Primary Outcome Measures:
  • Gather clinical outcome data on DTRAX Graft. [ Time Frame: Baseline throughout 12 months post-operatively ] [ Designated as safety issue: No ]
    Clinical outcome data will be collected using the Neck Disability Index (NDI), Visual Analogue Scale (VAS), and a quality of life questionnaire.


Secondary Outcome Measures:
  • Safety information will be evaluated by collecting the type, frequency, severity, device, and procedure-relatedness of adverse events. [ Time Frame: Baseline throughout 12 months post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DTRAX graft Device: DTRAX Graft
DTRAX Graft is an allograft implant inserted to support spinal fusion.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject diagnosed with DDD in C3-C7, defined as follows:

    • Radiographically (at least one):

      • degenerated disc on MRI;
      • decreased disc height on plain film, CT or MRI; and/or
      • disc herniation, as demonstrated by CT or MRI.
    • Clinically: radicular symptoms (at least one):

      • arm/shoulder pain;
      • decreased reflexes;
      • decreased strength; and/or
      • decreased sensation.
  2. Subject has single-level disease, OR multi-level disease demonstrated radiographically, and confirmed to be symptomatic by one of the following methods:

    • Selective nerve root block, OR
    • EMG, OR
    • Distinctive clinical examination.
  3. Subject has dynamic stenosis relieved by traction and made worse by a Spurlings maneuver.
  4. Subject is 35-80 years of age, inclusive.
  5. Subject is unresponsive to 6 weeks conservative, nonoperative treatment, or has the presence of progressive symptoms or signs of nerve root compression in face of combined nonoperative management.
  6. Preoperative NDI score of ≥ 30.
  7. Preoperative neck pain and arm pain score of ≥ 6 on Neck and Arm Pain Scales.
  8. Patient is a male or non-pregnant, non-lactating female.
  9. Female patients of child-bearing potential, including those who have had a tubal ligation, but excluding those who have not experienced a menstrual period for at least two years, must have a negative urine pregnancy test at Screening.
  10. Patient must voluntarily provide written, informed consent.
  11. Subject is able to meet the proposed follow-up schedule.
  12. Subject is able to follow the postoperative management program.

Exclusion Criteria:

  1. Subject has severe osteopenia, osteoporosis, osteomalacia, spinal metastases, or metabolic bone disease OR the level of BMD is a T score of -2.5 or below OR patient has sustained a vertebral compression or nontraumatic hip or wrist fracture.
  2. Subject has overt or active spinal and/or systemic infection.
  3. Subject has spondylolisthesis ≥ 3.5mm or rotator subluxation.
  4. Subject has cervical myelopathy.
  5. Subject has a chronic pain syndrome.
  6. Subject has radicular findings with major motor impairment.
  7. Subject has a condition that requires postoperative medications that interfere with fusion or the stability of the implant, such as steroids.
  8. Subject is mentally incompetent.
  9. Subject is a prisoner.
  10. Subject is pregnant.
  11. Subject abuses alcohol or drugs.
  12. Subject has a cervical spinal condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level.
  13. Subject has insulin dependent diabetes.
  14. Subject has chronic or acute renal failure or prior history of renal disease.
  15. Subject has fever at the time of surgery, defined as > 38.5 degrees C.
  16. Subject has documented allergy or intolerance to stainless steel, titanium, or a titanium alloy.
  17. Subject has received drugs which may interfere with bone metabolism within two weeks prior to the planned date of DTRAX surgery.
  18. Subject has history of an endocrine or metabolic disorder known to affect osteogenesis .
  19. Subject has had treatment with an investigational therapy within 28 days prior to DTRAX surgery or such treatment is planned during the 16 weeks following implantation of DTRAX Graft.
  20. Subject is involved in spinal litigation or Workmen's Compensation claim.
  21. Subject is obese, defined as body mass index (BMI) > 35.
  22. Patient has psychiatric history, head injury or any other condition, which, in the Investigator's opinion, would prevent the patient from complying with postoperative follow-up visits.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616719

Locations
United States, California
Neurospine Institute Medical Group
San Francisco, California, United States, 94115
Office of Dr. Brian Andrews, Neurosurgery
San Francisco, California, United States, 94114
Sponsors and Collaborators
Providence Medical Technology, Inc.
Investigators
Principal Investigator: Bruce McCormack, M.D. Neurospine Institute Medical Group
Principal Investigator: Brian Andrews, M.D. Office of Dr. Brian Andrews, Neurosurgery
  More Information

No publications provided

Responsible Party: Providence Medical Technology, Inc.
ClinicalTrials.gov Identifier: NCT01616719     History of Changes
Other Study ID Numbers: PMT002
Study First Received: June 7, 2012
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Radiculopathy
Spinal Diseases
Intervertebral Disc Degeneration
Spondylosis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014